New ISTSS Guidelines

The ISTSS Board has created a Guidelines Committee to produce updated Treatment Guidelines for PTSD informed by the research evidence base. It is envisaged that the updated Treatment Guidelines will be included in part in the third revision of the Effective Treatments book, and they will be disseminated on the ISTSS Website.

The Committee includes experts from various areas, including members with considerable systematic review and guideline development expertise. The table below lists the Committee members along with their specific areas of responsibility/expertise. The Committee will work as a team and collectively review the evidence and make decisions.

A consumer (PTSD sufferer/ex-PTSD sufferer and practitioner) perspective will be obtained through practitioner and non-practitioner consumer reference groups.

Methodology

Given the limited funding available to the committee, it will not be possible to commission new comprehensive systematic reviews in every area. It is, however, possible to develop a robust and replicable process that systematically gathers and considers the evidence currently available for any intervention (including less widely known ones) in a standardised manner, and makes decisions on recommendations based on a priori agreements. A process adapted from approaches taken by ACPMH, the Cochrane Collaboration, NICE and WHO to evidence evaluation and guideline development has the potential to achieve this.

The committee will agree on general scoping questions in a PICO (Population, Intervention, Comparator, Outcomes) format (for example, “For adults with PTSD, do psychological treatments when compared to treatment as usual, waiting list or no treatment, result in a clinically important reduction of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”) for the prevention and treatment of ASD and PTSD in children, adolescents and adults.

Searches will be undertaken to identify high quality (criteria to be agreed) systematic reviews that address the scoping questions. These will be used as the basis of the evidence to be considered and re-evaluated according to the criteria agreed for the ISTSS Treatment Guidelines (e.g. assessment of relevant clinical factors, including expert fidelity checks). Existing reviews will be supplemented with additional systematic searches for more recent information. If no systematic review has been undertaken, one will be commissioned.

All evidence will be supplemented by contacting a list of leading experts and asking the ISTSS membership (via its website) to determine if there are any missing studies.

A hierarchy of evidence will be followed, with Grade A evidence requiring more than a single randomised controlled trial.

The Cardiff Traumatic Stress Research Group will summarize the evidence for each of the scoping questions and grade the quality of evidence using the GRADE[1] system (the level of confidence that the estimate of the effect of an intervention is correct) and produce summary tables as per the Cochrane review examples shown below. The tables will be scrutinized by the committee before being finalized.

[1]GRADE Working Group grades of evidenceHigh quality: Further research is very unlikely to change our confidence in the estimate of effect.Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.Very low quality: We are very uncertain about the estimate.

The Committee will discuss the evidence tables and agree on the draft recommendations to be made. Ahead of data analysis, the committee will agree on the basis on which recommendations should be made. Different guideline development groups have taken a number of different approaches in the past and recommendations will be based on factors including quality of the evidence (GRADE score), effect size and likelihood of clinical benefit.

The Committee will aim to make decisions by consensus but where there is disagreement a vote will be taken and a majority required for a decision to be carried. The draft recommendations will be posted on the ISTSS website for a period of consultation and then finalized with the aim being for them to be considered by the ISTSS Board at their meeting in November 2017.

ISTSS Treatment Guidelines Final Scoping Questions

Following consultation with the ISTSS membership, practitioner and non-practitioner consumer reference groups, the ISTSS Guidelines Committee has agreed to 20 scoping questions for the update of the ISTSS Treatment Guidelines.

In addition to the comments received during the consultation, the following points have informed the selection of the questions:

The committee considered including separate draft scoping questions on treatments for complex presentations of PTSD for children, adolescents and adults. Concerns were raised that, due to definitional issues and, with very few exceptions, absence of studies specifically designed to answer possible scoping questions, their inclusion would be unlikely to provide clear answers. This, along with the current controversy within the field and desire to facilitate resolution of this, led to agreement that a degree of caution should be exercised. The committee concluded that rather than systematically reviewing the evidence for the treatment of complex presentations of PTSD it would be likely to be more beneficial to undertake a narrative review of the current situation with respect to “complex PTSD”, what it is and how it should be defined to enable the development of an evidence base of how best to treat it.

It is, therefore, proposed that a position paper is developed as part of the guidelines that considers the current issues around complex PTSD and makes recommendations to facilitate further research.

It was agreed that some sub-group analyses could be undertaken with data from the main PTSD treatment meta-analyses to consider if there appear to be differences in treatment effects for certain population groups.

It was agreed that with respect to psychological treatments for PTSD, different forms of cognitive and behavioural therapies with a trauma focus should be considered separately, with further work required to define groupings (e.g. BEP, cognitive therapy, cognitive processing therapy, exposure therapy, NET and STAIR-MPE).

It was agreed that further work will be required to determine the definition to be used for “clinically important” and that this will be done before the meta-analyses are undertaken.

It was agreed that PTSD should be the term searched for in systematic reviews of the treatment literature but that other conditions/symptoms should also be considered as secondary outcomes (e.g. depression, anxiety).

It was agreed that for early interventions following traumatic events, the search could be broader (prevention of all psychological symptoms) as specified in the scoping questions.

ISTSS Treatment Guidelines – Final Scoping Questions

“For children and adolescents within the first three months of a traumatic event, do psychosocial interventions when compared to intervention as usual, waiting list or no intervention, result in a clinically important reduction/prevention of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For children and adolescents within the first three months of a traumatic event, do psychosocial interventions when compared to other psychosocial interventions result in a clinically important reduction/prevention of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For adults within the first three months of a traumatic event, do psychosocial interventions when compared to intervention as usual, waiting list or no intervention, result in a clinically important reduction/prevention of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For adults within the first three months of a traumatic event, do psychosocial interventions when compared to other psychosocial interventions result in a clinically important reduction/prevention of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For children and adolescents within the first three months of a traumatic event, do pharmacological interventions when compared to placebo result in a clinically important reduction/prevention of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For children and adolescents within the first three months of a traumatic event, do pharmacological interventions when compared to other pharmacological or psychosocial interventions result in a clinically important reduction/prevention of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For adults within the first three months of a traumatic event, do pharmacological interventions when compared to placebo result in a clinically important reduction/prevention of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For adults within the first three months of a traumatic event, do pharmacological interventions when compared to other pharmacological or psychosocial interventions result in a clinically important reduction/prevention of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For children and adolescents with clinically relevant post-traumatic stress symptoms, do psychological treatments when compared to treatment as usual, waiting list or no treatment, result in a clinically important reduction of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For children and adolescents with clinically relevant post-traumatic stress symptoms, do psychological treatments when compared to other psychological treatments, result in a clinically important reduction of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For adults with PTSD, do psychological treatments when compared to treatment as usual, waiting list or no treatment, result in a clinically important reduction of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For adults with PTSD, do psychological treatments when compared to other psychological treatments, result in a clinically important reduction of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For children and adolescents with clinically relevant post-traumatic stress symptoms, do pharmacological treatments when compared to placebo result in a clinically important reduction of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For children and adolescents with clinically relevant post-traumatic stress symptoms, do pharmacological treatments when compared to other pharmacological or psychosocial interventions result in a clinically important reduction of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For adults with PTSD, do pharmacological treatments when compared to placebo result in a clinically important reduction of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For adults with PTSD, do pharmacological treatments when compared to other pharmacological or psychosocial interventions result in a clinically important reduction of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For children and adolescents with clinically relevant post-traumatic stress symptoms, do non-psychological and non-pharmacological treatments/interventions when compared to treatment as usual, waiting list or no treatment, result in a clinically important reduction of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For children and adolescents with clinically relevant post-traumatic stress symptoms, do non-psychological and non-pharmacological treatments/interventions when compared to other treatments, result in a clinically important reduction of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For adults with PTSD, do non-psychological and non-pharmacological treatments/interventions when compared to treatment as usual, waiting list or no treatment, result in a clinically important reduction of symptoms, improved functioning/ quality of life, presence of disorder, or adverse effects?”

“For adults with PTSD, do non-psychological and non-pharmacological treatments/interventions when compared to other treatments, result in a clinically important reduction of symptoms, improved functioning/quality of life, presence of disorder, or adverse effects?

The ISTSS Guidelines Committee is very grateful for the helpful comments received on the definition of "clinical importance". The definition has now been agreed and represents what will constitute a "clinically important" impact of an intervention (in other words, "Does treatment X result in a clinically important reduction of symptoms”).

Definition of “Clinically Important”

PTSD symptom change will be the primary outcome measure and other outcomes (e.g. diagnosis, functioning, other symptom change, tolerability) will be considered as secondary outcome measures.

The clinically important definition will be based on both magnitude of change and strength/quality of evidence.

Informed by previous work in this area (e.g. the NICE guidelines for PTSD development group), to be rated clinically important, an intervention will have to demonstrate an effect size for continuous outcomes of >0.8 for wait list control comparisons, >0.5 for attention control comparisons (no meaningful treatment, but same dosage of time/same number of sessions with a therapist) and >0.4 for placebo control comparisons.

If there were only one RCT, an intervention would not normally be recommended as clinically important. Non-inferiority RCT evidence alone will not be enough to recommend an intervention as clinically important.

Unless there is a GRADE quality of evidence rating of high or moderate1, consideration will be given to downgrading the strength of recommendation made with respect to clinical importance.

1 High quality: Further research is very unlikely to change our confidence in the estimate of effect; Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate; Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate; Very low quality: We are very uncertain about the estimate.